Long-term Prednisone Use for End-stage Heart Failure

January 11, 2017 updated by: Kun-shen Liu M.D., Hebei Medical University

Long-term Prednisone Use in Patients With Advanced Heart Failure (ACCF/AHA Stage D) and Hyperuricemia

Patients with advanced (ACCF/AHA stage D) heart failure and hyperuricemia have high one-year mortality. Currently, there was no evidence-based therapy such as mechanically assisted circulatory support available in China. The investigators found glucocorticoid treatment such as prednisone could improve cardiac performance, potentiate renal responsiveness to diuretics in such patients. Therefore, it could be used as bridge therapy to help ACE inhibitors or beta blocker titration. With its help, most of the patients with stage D heart failure could be titrated to higher dose of ACE inhibitors and beta blockers during hospitalization. However, the efficacy of long-term, low-dose of prednisone use in such patients with limited life expectancy remain unclear. Therefore, the investigators designed this study to observe whether putting low-dose of prednisone on the patients with stage D heart failure for long term could further improve their survival. All patients will receive prednisone treatment during hospitalization and receive maximum tolerated guideline-directed medical therapy (GDMT). After discharge from hospital, the patients will be randomized to receive long-term, low-dose prednisone treatment or standard GDMT.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050031
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Repeated (>2) hospitalizations or ED visits for HF in the past year
  • Inability to exercise including exertion limited, exertion intolerance, resting symptoms or inotrope dependent
  • Left ventricular ejection fraction ≤35%
  • Serum uric acid level ≥500μmol/L

  • Received prednisone treatment during hospitalization period and And more 5 of the followings

    1. Progressive deterioration in renal function (e.g., rise in BUN and creatinine)
    2. Weight loss without other cause (e.g., cardiac cachexia)
    3. Intolerance to ACE inhibitors due to hypotension and/or worsening renal function
    4. Intolerance to beta blockers due to worsening HF or hypotension
    5. Frequent systolic blood pressure <90 mm Hg
    6. Recent need to escalate diuretics to maintain volume status, often reaching daily furosemide equivalent dose >160 mg/d and/or use of supplemental thizide therapy
    7. Progressive decline in serum sodium, usually to <133 mEq/L
    8. Gastrointestinal symptoms (abdominal discomfort, nausea, poor appetite), disabling ascites, or severe lower-extremity edema

Exclusion Criteria:

  • Any condition (other than heart failure) that could limit the use of prednisone
  • Any concurrent disease that likely limits life expectancy;
  • Active myocarditis, or an hypertrophic obstructive or restrictive cardiomyopathy;
  • Myocardial infarction, stroke, unstable angina, or cardiac surgery within the previous 3 months;
  • Indication for hemodialysis
  • Uncontrolled systolic blood pressure > 160 mmHg
  • Complex congenital heart disease
  • Poorly controlled diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prednisone
Prednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months.
Drug: prednisone
Prednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months
No Intervention: Control
Maximum tolerated guideline-directed medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality within 12 months
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Event-free survival time (defined as time to first hospitalization due to heart failure deterioration or death) within 12 months
Time Frame: 12
12
Survival time (defined as time to death) within 12 months
Time Frame: 12 months
12 months
Change from baseline in serum uric acid
Time Frame: month 6 and month 12
month 6 and month 12
Change from baseline in serum creatinine
Time Frame: month 6 and month 12
month 6 and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hebmu 201312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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